The present invention relates to a hand operated valve for controlling the flow of at least one, and preferably both, irrigation fluid and suction to and from a surgical site and a valving method therefor.
During medical procedures, it is common to irrigate or wash a wound with sterilized fluid (herein xe2x80x9cirrigation fluidxe2x80x9d). Further, during laproscopic surgical procedures, the physician or other health professional (sometimes herein identified as xe2x80x9can operatorxe2x80x9d) may utilize the irrigation fluid for hydrodissection. In both procedures, the irrigation fluid is provided via a source line from a source or reservoir of fluid. Many times, the irrigation fluid is provided under pressure (for example, 5-15 psi) to the surgical site.
Physicians and other health professionals also utilize suction to remove spent irrigation fluid, other bodily fluids and debris which may accumulate at the wound site or surgical site. In certain medical procedures, the physician utilizes suction to remove gas. Gas is sometimes used to create an operable cavity at a laproscopic surgical site. Suction, or negative air pressure (some pressure below the ambient pressure), is created in a suction source line via a vacuum source and a sump. As used herein, the term xe2x80x9csuction sourcexe2x80x9d or xe2x80x9csource of suctionxe2x80x9d refers to a supply of negative air pressure. Although from a strictly scientific view point, suction is not created from xe2x80x9ca suction source,xe2x80x9d the negative pressure developed by the vacuum pump is a resource used by the physician or other health professional. If the vacuum pump fails to operate properly, the resource or source of suction is no longer available to the physician. In a similar manner, if the reservoir of the irrigation fluid dissipates, the source of irrigation fluid is no longer available for use by the physician. In this sense, the present invention utilizes a source of suction.
U.S. Pat. No. 5,522,796 to Dorsey discloses a metered and gauged trumpet valve utilized to control irrigation fluid to a surgical site and suction applied to a suction line leading to the surgical site. As disclosed in Dorsey ""796, the output of the metering valve is a single delivery line leading to the surgical site. Irrigation fluid is turned ON and OFF via the valve control and suction is turned ON and OFF based the controllable positions of valve stems in the metering valve. The Dorsey ""796 metering valve includes a rotatable operator control surface which has a normally disposed plate with a slope control or a cam surface. A generally cylindrical valve stem has a shoulder about its periphery upon which rests a gear having sloped control shapes or a sloped cam surface. The gear is keyed to the cylindrical valve stem. When the operator rotates the operator control surface, the cam shaped valve control surface affixed to the operator control rotates thereby changing the contact point on the sloping cam surface. The control sloping cam surface moves on the sloped cam surface of the valve stem gear thereby changing the vertical limit or stop position of the valve stem. By rotating the operator control surface, the valve opens to one of several gauge positions. At the other end of the valve stem, flow control is achieved between the stem and a valve body. The valve stem is biased in a direction to either fully open or fully close the irrigation and/or suction flow through the valve body. Preferably, the valve is biased closed. The physician can provide variable flow control by depressing the valve stem against the biasing enforce of the spring thereby opening or closing the valving aperture and the valve body. By rotating the control surface, the physician can establish preset flow control points or limits for the throw of the valve stem. An example of the use of a preset flow control is providing a low level of irrigation fluid at the surgical site. At the same time, the physician may operate the suction control valve from a fully OFF position to a fully ON position by depressing the valve stem vertically thereby opening the valving aperture between the valve stem and the valve body. In a preferred embodiment, the initial valve positions are in a blocking or OFF position thereby blocking irrigation fluid flow to the surgical site and blocking suction from the surgical site. The metered valve in Dorsey ""796 is generally rectangular in shape with the irrigation source line and suction source line affixed to the valve at a position normal to the delivery line. As stated earlier, the delivery line carries irrigation fluid to the surgical site and, at a different valve setting, provides suction and vacuum from the surgical site.
U.S. Pat. No. 5,391,145 to Dorsey discloses an irrigation control for endoscopic unit. U.S. Pat. No. 5,573,504 to Dorsey discloses a composite irrigation suction probe and valve. U.S. Pat. No. 5,679,111 to Hjertman discloses a device for dosing a liquid preparation. This ""111 patent discloses an injection device provided for continuously variable metering and administration of a liquid preparation. The device has a holder for a multi-dose injection cartridge. U.S. Pat. No. 5,674,204 to Chanoch discloses a medication delivery pen cap with an actuated dose delivery clutch. U.S. Pat. No. 5,599,314 to Neill discloses a syringe with an incrementally actuated plunger. U.S. Pat. No. 4,883,472 to Michel discloses an injection device with utilizes an exchangeable pre-filled syringe.
The following patents disclose valving systems that are not utilized in surgical procedures.
U.S. Pat. No. 5,456,448 to Chou (discloses a touch button controlled water stop mounted in a fixed pipe line carrying water, e.g. water to a shower); U.S. Pat. No. 5,421,552 to Wang et al. (discloses a foot operated valve); U.S. Pat. No. 4,956,755 to Maglice et al. (discloses a two position mechanical switch to control a flashlight); U.S. Pat. No. 4,383,477 to Nilsson et al. (discloses a ventilator valve control); U.S. Pat. No. 4,106,508 to Berlin (discloses a clamp used for occlusion of blood vessels); U.S. Pat. No. 4,771,985 to Gross et al. (discloses a hand controlled faucet); U.S. Pat. No. 3,220,695 to Downey et al. (discloses a push button drain valve); U.S. Pat. No. 3,046,802 to Cupedo (discloses a stop valve); U.S. Pat. No. 4,221,236 to Rosenberg (a step valve); U.S. Pat. No. 4,221,238 to Madsen (an intermittent valve); U.S. Pat. No. 5,546,983 to Clare (a shut off valve); and U.S. Pat. No. 5,806,404 to Sher (a rotary piston valve).
There is a need for an in-line hand operated valve that is simple to use and that easily fits within the hand of an operator.
It is an object of the present invention to provide an in-line, hand operated valve for controlling one, and preferably both, medical irrigation fluid and suction to and from a surgical site.
It is another object of the present invention to provide a cylindrical or a torpedo shaped hand held valve for controlling irrigation fluid and suction to and from a surgical site.
It is another object of the present invention to provide a valve and a valving method whereby the operator control surfaces are on opposing sides, the mechanical valving switch systems in the valve provide audible, tactile and preferably both audible and tactile responses to the operator.
It is another object of the present invention to provide a variable flow control by permitting the operator to depress the operator control surface and hence the valve stem through a throw distance between a click open and a click close position.
It is a further object of the present invention to utilize a click open and click close mechanism similar to that used in connection with ball point pen cartridge controls which, during a click open operation, causes the point of the ink cartridge to protrude beyond the pen body and, during a click close operation, causes the ink pen cartridge tip to retract within the pen body.
It is a further object of the present invention to provide click open and click close operator control surfaces at opposing sides of the cylindrical or torpedo shaped valve body.
It is another object of the present invention to provide the operator control surfaces at a positions substantially maintaining the cylindrical shape or the torpedo shape of the valve body when the valve blocks or closes OFF irrigation flow and suction flow through the valve body.
It is another object of the present invention to provide an irrigation and suction flow control valve which is simple to manufacture, inexpensive and easy to operate.
It is a further object of the present invention to provide an irrigation and suction control valve which is disposable.
The in-line hand operated valve controls the flow of at least one, and preferably both, medical irrigation fluid and suction respectively to and from a surgical site via a delivery line. In one working embodiment, irrigation fluid is supplied to the valve via a first source line and suction is supplied to the valve via a second source line. The valve body defines, in a working embodiment, source ports in fluid communication with the irrigation source fluid line and the suction source line. At the other end of the valve body, a delivery port is defined and is in fluid communication with the delivery line. The valve body includes at least one, and preferably two, internal fluid carrying channels. The internal channel is in fluid communication with the respective source port and the delivery port. At least a portion of the internal fluid carrying channel is substantially collapsible. The valve includes an operator actuated stem (in a working embodiment two stems, one for each of the irrigation valve switch and the suction valve switch) having a compressor member acting on and closing and opening the collapsible segment of the fluid carrying channel or fluid carrying body. A biasing element (such as a spring or other resilient body) keeps the valve stem and the compressor element in either an open or a closed state. A two position interlocking mechanical switch is coupled to the valve stem. In one position, the compressor element is extended and in a second position, the compressor element is withdrawn to achieve the open and closed state of the fluid carrying channel or body. In a working embodiment, two valve stems are used, each with a compressor member, two independent biasing elements are utilized and two mechanical two position switches are utilized. Further enhancements include operator control surfaces that are on opposing side wall surfaces of the generally cylindrical or torpedo shaped valve body. In a preferred embodiment, the valve is normally closed and the operator control surfaces are substantially co-extensive with the cylindrical or torpedo shaped valve body. To open the valves, the control surfaces are depressed thereby enabling the operator to quickly detect the state of valve position without visual confirmation (a tactile response system). Another enhancement of the present invention includes utilization of audible clicks to notify the operator when the open or closed state is achieved by each mechanical switch system controlling the position of the valve stem and the compressor member. The method of providing a valve control utilizes these shape and click open and click close switch systems.